A Study of BION-1301 in Adults With IgA Nephropathy

Status Recruiting

Clinical Trial Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Clinical Trial Description

Approximately 272 patients with eGFR ≥ 30 mL/min/1.73m^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy. Subjects will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05852938
Study type	Interventional
Source	Chinook Therapeutics, Inc.
Contact	Novartis Pharmaceuticals
Phone	1-888-669-6682
Email	novartis.email@novartis.com
Status	Recruiting
Phase	Phase 3
Start date	July 27, 2023
Completion date	May 8, 2028

View Details

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